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Navigate Compliance, Technology and Supply Logistics to Enable Virtual/Hybrid Trials

August 8-9, 2019
  • Philadelphia, PA

As industry moves towards a more patient-centric approach, the direct-to-patient clinical trial model stands out as a natural next step in the realm of trial innovation. Despite the benefits for both patients and sponsors, adoption of the siteless/DtP/virtual/remote model presents a novel set of challenges that must be triumphed relating to trial operationalization, protocol development, technology use, supply management and regulatory compliance.

CBI’s 2nd Annual Direct-to-Patient Clinical Trials provides a unique opportunity to collaborate with industry pioneers through a mix of real-world examples, interactive discussions and engaging panels to navigate this emerging landscape and successfully enable direct-to-patient trials.

High-Impact Topics Transforming the Clinical Trial Landscape:

  • Assess key factors to determine when a virtual, hybrid or traditional model is the best fit for a clinical trial
  • Identify unexpected challenges to recruitment and
    conduct in a siteless trial
  • Evaluate, implement and maintain new technology
  • Break down current CTTI and FDA guidance documents on decentralized trials
  • Restructure traditional supply chains to adapt to
    siteless models
  • Partner with home healthcare providers to enable
    virtual and hybrid trials
  • FDA Perspective Clinical Trial Innovation and the Current
    Regulatory Landscape for Decentralized Trials
  • Patient Perspective Harness Patient Feedback to Design
    Improved Trial Models
  • Lessons Learned Barriers to Virtual Trial Success and
    Key Takeaways for Future Trials

Previous Attendee Acclaim:

Great compilation of topics and speakers; discussions were helpful and insightful. Provided a wealth of information to consider as we delve into this area
and set our organization up for success.

Executive Director, Business Operations, Astellas Pharma